BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Kara Lorduy

Principal Investigator
Fatma Gul, M.D.

Official Title

BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study

Brief Overview

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the
treatment of pediatric upper limb spasticity.

Participant Eligibility

Inclusion Criteria:

- Minimum weight of 10 kg/22 lb

- Upper limb spasticity due to cerebral palsy or stroke

Exclusion Criteria:

- Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
sclerosis, or mitochondrial disease

- Uncontrolled epilepsy

- Botulinum Toxin therapy of any serotype for any condition within the last 3 months

- History of surgical intervention of the upper limb within 1 year, or planned surgery
of any limb during the study